Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Analgesics, Opioid

Narcotics

Patients with chronic pain responsive to intrathecal opioid analgesia as demonstrated in a morphine trial or patients with a previous successful intrathecal opioid therapy with an implantable pump will undergo study device implantation .

Patients with chronic pain responsive to intrathecal opioid analgesia as demonstrated in a morphine trial or patients with a previous successful intrathecal opioid therapy with an implantable pump will undergo implantation of pump for intrathecal delivery of Morphine Sulfate.

Implantation of Morphine Sulfate delivering programmable pump

Richard Rauck, MD

• The objectives of this study are to confirm the medication delivery accuracy of the Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain control.

The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain

THE CLINICAL EVALUATION OF IMPLANTABLE PUMP SYSTEM FOR SAFETY AND DELIVERY ACCURACY IN PATIENTS REQUIRING INTRATHECAL ADMINISTRATION OF MORPHINE SULFATE FOR CHRONIC PAIN

Medication delivery accuracy will be evaluated at each of six (6) refills.

Tabulation of Concomitant Medications, Tabulation of Physical and Neurological, Exam, Summary of Vital Signs, Incidence of Inflammatory Masses, Summary of COWS

Medallion Therapeutics, Inc.

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Substance Related Disorders

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neurotoxicity Syndromes

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Neuroprotective Agents

Cytarabine

Dexamethasone

Methotrexate

Prednisolone

Dexamethasone acetate

Methylprednisolone

Cortisone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protective Agents

Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL

Intrathecal methotrexate, cytarabine and prednisolone

Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL

Liposomal cytarabine

Intrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol

Intrathecal triple

Arja Harila-Saari, MD

* Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.
* Both acute and long-term toxicity are equal in both treatment arms.

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

1. To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
2. To evaluate acute and long-term toxicity in both treatment arms.

Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)

Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol

Oulu University Hospital

Nordic Society for Pediatric Hematology and Oncology

Associate professor

Skin and Connective Tissue Diseases

Digestive System Diseases

Leiomyoma

Myofibroma

Ileus

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

Antipyretics

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Anticonvulsants

Psychotropic Drugs

Oxycodone

Anesthetics

Acetaminophen

Ibuprofen

Lidocaine

Bupivacaine

Hydromorphone

Ketorolac

Ketorolac Tromethamine

Celecoxib

Gabapentin

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

* Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital
* Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol.
* Intraoperative: dexamethasone and epidural bupivacaine
* Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine
* Postoperative: hydromorphone PCA, ibuprofen, oxycodone

* Day or surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg)
* Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight
* Day of surgery postoperative: toradol, ibuprofen, tylenol
* Postoperative: ibuprofen, oxycodone, and hydromorphone prn

-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP

-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)

-Lidocaine infusion 1 mg/kg ideal body weight (IBW)

Premal H Thaker, M.D., MS

Lindsay Kuroki, M.D., MSCI

Lara Crock, M.D., Ph.D.

To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).

Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.

-Defined by bilious emesis requiring a change in diet to nothing-per-mouth (NPO) status or nasogastric tube placement (NGT) in the absence of other indications. Patients who had NGT placed prophylactically at the time of surgery were not considered to have an ileus unless an NGT was reinserted or they met the above criteria. Participants will be assigned a value of yes ileus or no ileus. The rate of post op ileus is defined as the observed number of yes ileus in each study arm divided by the total number of subjects in the study arm. Fisher's exact test will be used to compare non-paired nominal data.

-Length of stay will be determined by the dates of admission as recorded on EPIC (days).

-Postoperative hypotension will be defined as \<90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.

-Patients will be asked on day of discharge if they were satisfied with their pain control during their hospitalization. They will be able to choose from the following: 0=satisfied, 1= somewhat satisfied, 2= neutral, 3=somewhat dissatisfied, 4=dissatisfied).

-Pain scores will be determined by the 0-10 numeric rating scale (NRS). 0=no pain and 10=the most pain.

-As determined by an NRS pain score ≥ 5

Washington University School of Medicine

Adjuvants, Anesthesia

Vasoconstrictor Agents

Respiratory System Agents

Antihypertensive Agents

Fentanyl

Epinephrine

Racepinephrine

Epinephryl borate

Clonidine

The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.

The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.

Epidural

Intrathecal

The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.

Recovery and Analgesia After Surgery for Gynecological Cancer

Will Intrathecal Analgesia Contribute to a Faster Recovery Compared With Epidural Analgesia After Open Surgery for Gynecological Cancer. An Open Controlled Randomized Study.

Pain at rest will be assessed using a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Pain is documented on the day of surgery (day 0), 3 times daily postoperative day 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35 and 42.

Scale: NRS Minimum value:0 Maximum value: 10. Higher scores indicate worse outcome.

From day of surgery (Day 0) until discharge after surgery

The questionnaire Short Form with 36 questions "SF-36" will be used preoperatively and at 6 weeks after surgery. The SF-36 consists of eight scaled subscores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental Health) and two Component summary scores (physical Component summary scoer, mental component summary score). A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Lena Nilsson

MD. PhD. Assoc professor.

The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the

The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.

Spinal

The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.

Epidural

Epidural Analgesia

The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.

Intrathecal

Intrathecal Analgesia

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Sweden

Region of Enrollment

Dr Lena Nilsson

Length of Stay

SF-36 Physical component summary score baseline

SF-36 Physical component summary score day 42

SF-36 mental component summary score baseline

SF-36 mental component summary score day 42

Change in Quality of Life

Pain at rest Day 0

Pain at rest Day 1

Pain at rest Day 2

Pain at rest Day 3

Pain at rest Day 4

Pain at rest Day 5

Pain at rest Day 6

Pain at rest Day 7

Pain at rest Day 14

Pain at rest Day 21

Pain at rest Day 28

Pain at rest Day 35

Pain at rest Day 42

Change in Pain

Overall Study

Pain, Postoperative

Postoperative Complications

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%

intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain	NCT01185470	Cancers Chronic Pain	Implantation of...	21 Years -	Medallion Therapeutics, Inc.
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)	NCT00991744	Acute Lymphobla...	Liposomal cytar... Intrathecal tri...	1 Year - 18 Years	Nordic Society for Pediatric Hematology and Oncology
The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain	NCT01185470	Cancers Chronic Pain	Implantation of...	21 Years -	Medallion Therapeutics, Inc.
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy	NCT05017246	Cancer Debulkin... Enlarged Uterus Fibroid Uterus Adnexal Mass	Bupivacaine Morphine Lidocaine	18 Years -	Washington University School of Medicine
Recovery and Analgesia After Surgery for Gynecological Cancer	NCT02026687	Gynecological C...	Epidural Intrathecal	18 Years - 70 Years	University Hospital, Linkoeping
Combined Intrathecal Morphine and Dexmedetomidine Analgesia	NCT02435537	Postoperative P...	Dexmedetomidine... Bupivacaine Morphine	30 Years - 60 Years	Assiut University
Intrathecal Double Checkpoint Inhibition	NCT05598853	Leptomeningeal ... Non-small Cell ... Melanoma Stage ...	intrathecal niv...	18 Years - 100 Years	University of Zurich
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow	NCT01567345	Advanced Cancer Intractable Pai...	Implantable pum... Implantable pum...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for intrathecal

Every month we try and update this database with for intrathecal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for intrathecal

Every month we try and update this database with for intrathecal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for intrathecal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.